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Name:Aspirin
Manufacturer:Moore Medical Llc
Category:Over-the-counter (OTC) Marketed Drugs


Moore Brand® Aspirin (NSAID)

ASPIRIN - aspirin tablet, film coated 
Moore Medical LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Moore Brand® Aspirin (NSAID)

Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • backache
  • common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever.

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • blisters
  • shock

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcohol drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • if you are taking prescription drugs for gout, diabetes or arthritis

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • drink a full glass of water with each dose

Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Other information

  • read all product information before using
  • store at room temperature 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide*.

*may contain

Questions or comments? 1-800-234-1464

116R MM Aspirin Label

moore medical

the supply company

UPN# 0-0607415-8767-5

Moore Brand®

Aspirin (NSAID)

250 Packets/2 Tablets

Each Packet Net Wt. 650 mg

Aspirin 325 mg

See new warnings information

Reorder No. 87676

To Reorder:

Call: 1.800.234.1464

Fax: 1.800.944.6667

Online: www.mooremedical.com

116R MM Aspirin Label

ASPIRIN 
aspirin tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55670-676
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
STARCH, CORN  
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code 44;157;Aspirin
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55670-676-13 250 PACKET (250 PACKET) in 1 BOX contains a PACKET (55670-676-99)
1 NDC:55670-676-99 2 TABLET, FILM COATED (2 TABLET) in 1 PACKET This package is contained within the BOX (55670-676-13)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 12/30/2008

Labeler - Moore Medical LLC (051420107)

Revised: 11/2010 Moore Medical LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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